The director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada–Las Vegas detailed the steps necessary to lower wasted costs from Alzheimer disease drug development and improve regulatory success. [WATCH TIME: 4 minutes]
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"We really do need to be far more disciplined about stopping drugs. I think the biomarkers are going to be helpful. We have not had target engagement biomarkers that allowed us to understand whether the drug was hitting the target. Now we do.”
Since 1995, an estimated $42.5 billion has been spent in cumulative private expenditures on funding the research and development of Alzheimer disease (AD) medications, with little regulatory success to show for. Aside from the recent approval of aducanumab (Aduhelm; Biogen), there have only been 5 novel drugs—all for symptomatic treatment—to reach FDA approval.
Those costs were recently calculated in a published paper by Jeffrey Cummings, MD, ScD, et al that collected information on a total of 1099 AD clinical trials, ranging from phases 1-4, conducted from 1995-2021. The research highlighted the enormous sums of money being plunged into the AD space, as well as the countless failed trials that have come with it. Of that $42.5 billion, the greatest costs came from phase 3 trials, which accounted for 57% of the costs, totaling $24,065 million in private expenditures.
Cummings a professor of brain science and the director of the Chambers-Grundy Center for Transformative Neuroscience at University of Nevada–Las Vegas, sat down with NeurologyLive® to provide additional context on the next steps following this research. He detailed ways the AD community can begin to create positive change, stressed the need for industry leaders to recognize failures at earlier stages, and answered questions as to whether changes in efficacy measures would ensure greater drug success.